Osteo Arthritis KneeIntraOPNCT05966519
ROSA Knee Intraoperative Planning Flexibility Study
An observational study of Osteo Arthritis Knee and Rheumatoid Arthritis, run by Zimmer Biomet at 1 site in Japan.
Trial summary
The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Rheumatoid Arthritis
- What is being tested?
- Total Knee Replacement (TKR)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- 5 Jan 2024to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will comprise of males and females who require primary total knee arthroplasty and satisfy the inclusion/exclusion criteria outlined in this section of the protocol. In order to avoid potential selection bias, each Investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary total knee arthroplasty using the commercially available Zimmer Biomet total knee systems. Eligible candidates who express interest in study participation will be offered Informed Consent.
Who may be able to join
- 20 years and over
- Skeletally matured
- Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study
- Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form
Who cannot join
- Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
- Is septic, has an active infection or has osteomyelitis at the affected joint
- Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
- Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- Is known to be pregnant
- Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
- Has a known sensitivity or allergy to one or more of the implanted materials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Shinya Kawahara
About this study
Official title: ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study
The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.
Read the detailed description
The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique.
The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan \& intra-op final plan.
The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.
- Conditions
- Osteo Arthritis Knee, Rheumatoid Arthritis
- Being tested
- Total Knee Replacement (TKR)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Replacement (TKR)Device
Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses
| Study group | Role | What they receive |
|---|---|---|
| TKA with ROSA Knee | Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system Receives: Device: Total Knee Replacement (TKR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan
The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments
Measured: Immediate post-operative
Secondary outcomes (5)
Pain, range of knee motion and functional performance
The Knee Society Score 2011, and Physical Exam to evaluate pain, range of knee motion and functional performance
Measured: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
QOL
Subject quality-of-life will be measured by the EuroQol 5 dimensions 5-level (EQ-5D-5L)
Measured: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
Rehabilitation record
Recovery of patient will be assessed by prescribed Rehabilitation record and compliance
Measured: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
Kinematic analysis
Kinematic analysis will be conducted to visualize postoperative knee motion
Measured: Postoperative 12 months or 24 months
Image review (CT/Radiograph)
Image review (CT/Radiograph) to assess the accuracy of the implant position, radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc.
Measured: Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start5 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasuharu Nakashima, Principal investigator, Kyushu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966519
- Sponsor's protocol ID
- CSA2022-29TDS
- Acronym
- IntraOP
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT05966519
- Acronym / sponsor ID
- IntraOP / CSA2022-29TDS
- Conditions
- Osteo Arthritis Knee, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.
Detailed description
The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique.
The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan \& intra-op final plan.
The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKA with ROSA Knee | – | Device: Total Knee Replacement (TKR)Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise of males and females who require primary total knee arthroplasty and satisfy the inclusion/exclusion criteria outlined in this section of the protocol. In order to avoid potential selection bias, each Investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary total knee arthroplasty using the commercially available Zimmer Biomet total knee systems. Eligible candidates who express interest in study participation will be offered Informed Consent.
Key inclusion criteria (5 listed)
- 20 years and over
- Skeletally matured
- Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study
- Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form
Key exclusion criteria (7 listed)
- Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
- Is septic, has an active infection or has osteomyelitis at the affected joint
- Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
- Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- Is known to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee Replacement (TKR)Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses | Device | TKA with ROSA Knee |
Primary outcome
The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan
Time frame: Immediate post-operative
The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments
5 secondary outcomes
Pain, range of knee motion and functional performance
Time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
QOL
Time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
Rehabilitation record
Time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
Kinematic analysis
Time frame: Postoperative 12 months or 24 months
Image review (CT/Radiograph)
Time frame: Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasuharu Nakashima principal investigator
Kyushu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Knee and Rheumatoid Arthritis, run by Zimmer Biomet at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noriko Sugawara (+81-3-6402-6600, noriko.sugawara@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan (time frame: Immediate post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.